Surgical instrument with fastener preload lock-out

ABSTRACT

Surgical instruments and their methods of use are disclosed. In some embodiments, the surgical instrument may include a handle and an elongated shaft extending distally from the handle. The surgical instrument may also include a fastener deployment system for deploying fasteners from the elongated shaft including a reciprocating driveshaft disposed within the elongated shaft. In other embodiments, the fastener deployment system may include a follower disposed within the elongated shaft for displacing one or more fasteners within the elongated shaft towards a distal fastener deployment position. In some embodiments, the surgical instrument may include a removable preload lock-out attached to the elongated shaft to prevent the follower from applying a preload to the fasteners.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/697,354, filed Jul. 12, 2018 and U.S. Provisional Application No.62/798,178, filed Jan. 29, 2019. The entire contents of theseapplications are incorporated herein by reference in their entirety.

FIELD

Disclosed embodiments are related to a surgical instrument for deployingfasteners.

BACKGROUND

A surgical mesh fabric or other prosthetic repair fabric may be used tosurgically repair a hernia. The prosthetic repair fabric is typicallyplaced in an open procedure or laparoscopically. To secure the repairfabric in place, one or more fasteners may be deployed through theprosthetic repair fabric and into the underlying tissue. Oftentimes,surgical instruments used during the surgical repair of a hernia, orother appropriate procedure, include magazines, or other structures,that are capable of holding a plurality of fasteners for deployment fromthe surgical instrument. The inclusion of a plurality of fastenerswithin the surgical instrument may increase the speed of the procedureand may also reduce the need to remove and re-introduce the surgicalinstrument into a surgical field to provide additional fasteners.

SUMMARY

In one embodiment, a surgical instrument comprises a handle, anelongated shaft extending in a distal direction from the handle, atleast one fastener located within the elongated shaft, a fastenerdeployment system configured to deploy the at least one fastener fromthe elongated shaft in response to actuation thereof, and a lock-outremovably attached to the elongated shaft. The fastener deploymentsystem is configured to apply a first load to the at least one fastenerprior to actuation thereof. The lock-out is configured and arranged toprevent the fastener deployment system from applying the first load tothe at least one fastener while the lock-out is attached to theelongated shaft.

In another embodiment, a method is provided of operating a surgicalinstrument. The method comprises acts of: (a) providing a surgicalinstrument including a handle, an elongated shaft extending in a distaldirection from the handle, at least one fastener located within theelongated shaft, a fastener deployment system configured to deploy theat least one fastener from the elongated shaft in response to actuationthereof, the fastener deployment system configured to apply a first loadto the at least one fastener prior to actuation thereof, and a lock-outattached to the elongated shaft to prevent the fastener deploymentsystem from applying the first load to the at least one fastener. Themethod also comprises acts of (b) detaching the lock-out from theelongated shaft whereby the fastener deployment system applies the firstload to the at least one fastener, and (c) following act (b), actuatingthe fastener deployment system to deploy the at least one fastener fromthe elongated shaft.

In another embodiment, a surgical instrument comprises a handle, anelongated shaft extending in a distal direction from the handle, a stackof fasteners located within the elongated shaft, a fastener deploymentsystem configured to deploy at least one of the fasteners from theelongated shaft in response to actuation thereof, and a lock-out clipremovably attached to an exterior surface of the elongated shaft. Theelongated shaft includes an internal channel and a hole extending fromthe external surface to the internal channel. The stack of fasteners islocated within the internal channel of the elongated shaft. The fastenerdeployment system includes a follower which has a pusher configured toengage and apply a first load to the stack of fasteners. The lock-outclip includes a pin extending through the hole in the elongated shaftand into the internal channel of the elongated shaft. The pin is locatedbetween the stack of fasteners and the pusher to prevent the pusher fromapplying the first load to the stack of fasteners while the lock-out isattached to the elongated shaft.

In another embodiment, a lock-out is provided for a surgical instrumentincluding an elongated shaft, a stack of fasteners located within theelongated shaft, and a fastener deployment system to deploy a fastenerfrom the elongated shaft. The fastener deployment system is configuredto apply a preload to the stack of fasteners. The lock-out comprises agrip handle configured to be grasped and manipulated to attach anddetach the lock-out to and from the elongated shaft, the grip handleincluding first and second sides. The lock-out further comprises a firstpair of opposing clip fingers and a second pair of opposing clipfingers. The first and second pairs of clip fingers are configured toreceive the elongated shaft therebetween and engage an exterior surfacethereof. Each of the first and second pairs of clip fingers includes afirst clip finger and a second clip finger, the first clip fingers beinglocated at the first side of the grip handle and the second grip fingersbeing located at the second side of the grip handle. The first gripfingers are spaced a first distance from each other and the second gripfingers are spaced a second distance from each other, the first andsecond distances being different from each other.

In another embodiment, a lock-out is provided for a surgical instrumentincluding an elongated shaft, a stack of fasteners located within theelongated shaft, and a fastener deployment system to deploy a fastenerfrom the elongated shaft. The fastener deployment system is configuredto apply a preload to the stack of fasteners. The lock-out comprises agrip handle and a pin extending from the grip handle. The grip handle isconfigured to be grasped and manipulated to attach and detach thelock-out to and from the elongated shaft. The pin is configured tocooperate with the fastener deployment system when the lock-out isattached to the elongated shaft. The lock-out further comprises a shroudconfigured to shield the pin from contact by a user when the lock-out isdetached from the elongated shaft, and a pair of opposing clip fingersconfigured to receive the elongated shaft therebetween and engage anexterior surface thereof to detachably retain the lock-out on theelongated shaft.

In another embodiment, a surgical instrument system comprises a tray anda surgical instrument loaded in the tray. The surgical instrumentincludes a handle, an elongated shaft extending in a distal directionfrom the handle, a stack of fasteners located within the elongatedshaft, and a fastener deployment system configured to deploy at leastone of the fasteners from the elongated shaft in a distal direction inresponse to actuation thereof. The fastener deployment system isconfigured to engage and apply a first load to the stack of fasteners inthe distal direction prior to actuation thereof. The surgical instrumentsystem also comprises a lock-out removably attached to the elongatedshaft and a tether coupling the lock-out to the tray so that thelock-out remains attached to the tray when the lock-out is detached fromthe elongated shaft. The lock-out is configured and arranged to preventthe fastener deployment system from applying the first load to the stackof fasteners while the lock-out is attached to the elongated shaft.

It should be appreciated that the foregoing concepts, and additionalconcepts discussed below, may be arranged in any suitable combination,as the present disclosure is not limited in this respect. The foregoingand other aspects, embodiments, and features of the present teachingscan be more fully understood from the following description inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In thedrawings, each identical or nearly identical component that isillustrated in various figures may be represented by a like numeral. Forpurposes of clarity, not every component may be labeled in everydrawing. In the drawings:

FIG. 1 is a schematic representation of a surgical instrument fordeploying fasteners and includes a preload lock-out;

FIG. 2 is a schematic representation of the interior of the surgicalinstrument handle of FIG. 1;

FIG. 3 is a schematic exploded view of the elongated shaft and thecomponents disposed within the channel of the elongated shaft;

FIG. 4 is a schematic representation of a follower;

FIG. 5 is a schematic representation of a distal portion of thereciprocating driveshaft;

FIG. 6 is a schematic cross-sectional view of the follower locatedwithin the driveshaft;

FIG. 7A is a schematic representation of a stack of fasteners and thefollower in an unbiased position;

FIG. 7B is a schematic representation of the stack of fasteners and thefollower of FIG. 6 with a biasing force applied;

FIG. 7C is a schematic representation of the stack of fasteners and thefollower of FIG. 6 after the stack of fasteners have been distallydisplaced;

FIG. 8A is a schematic representation of a distal portion of theanti-backup mechanism;

FIG. 8B is a schematic representation of the anti-backup mechanismdepicted in FIG. 8A after one actuation cycle;

FIG. 9A is a schematic front view of a preload lock-out;

FIG. 9B is a schematic top view of the preload lock-out of FIG. 9A;

FIG. 10 is a schematic perspective view of the lock-out attached to theelongated shaft of the surgical instrument of FIG. 1 illustrating thelock-out preventing the follower from applying a preload to thefasteners;

FIGS. 11A-11C are schematic perspective views of the lock-out with ashroud for shielding the lock-out pin and a tether for attaching thelock-out to a tray;

FIG. 12 is a schematic perspective view of the shroud for the lock-outof FIGS. 11A-11C;

FIG. 13 is a schematic top view of a surgical instrument loaded in atray with the preload lock-out coupled to the tray with the tether;

FIG. 14 is a schematic perspective view of a tether for retracting thefollower extending from the proximal end of the handle;

FIG. 15 is a schematic perspective view of the rigid straight portionincluding first and second restraints;

FIG. 16 is a schematic end view of the rigid straight portion depictedin FIG. 15;

FIG. 17 is a schematic side view of the rigid straight portion depictedin FIG. 15;

FIG. 18 is a schematic side view of the rigid straight portion depictedin FIG. 17 rotated 120°;

FIG. 19A is a cross-sectional view of the elongated shaft, reciprocatingdriveshaft, and fasteners in the unactuated position;

FIG. 19B is a cross-sectional view of the elongated shaft, reciprocatingdriveshaft, and fasteners depicted in FIG. 19A in the actuated position;

FIG. 19C is a cross-sectional view of the elongated shaft, reciprocatingdriveshaft, and fasteners depicted in FIG. 19A after actuation;

FIG. 20 is a schematic exploded view of the elongated shaft and thereciprocating driveshaft including a stack of fasteners;

FIG. 21 is a schematic top view of a fastener;

FIG. 22 is a schematic bottom view of the fastener depicted in FIG. 21;

FIG. 23 is a schematic perspective view of the fastener depicted inFIGS. 21-22;

FIG. 24 is a schematic end view of the reciprocating driveshaftincluding a stack of fasteners disposed therein; and

FIG. 25 is a schematic end view of the elongated shaft with thereciprocating driveshaft and stack of fasteners disposed therein.

DETAILED DESCRIPTION

The inventors have recognized that the application of force, such as apreload, to a fastener for an extended period of time, such as duringshipping and/or storage of a surgical instrument loaded with one or morefasteners, may adversely affect mechanical, structural and/or materialproperties and/or characteristics of the fasteners. For example, whensubjected to a preload for an extended period of time prior to use ofthe surgical instrument, a stack of fasteners subjected to a preload mayundergo deformation during accelerated aging.

In view of the foregoing, the inventors have recognized the benefitsassociated with preventing the application of a force to one or morefasteners, including a stack of fasteners, prior to using the surgicalinstrument for deploying the fasteners. In some embodiments, this forcemay be a preload applied to the stack of fasteners for facilitatingfastener deployment. The above noted benefit may lead to improvedconsistency in fastener deployment and surgical instrument operation.

In one embodiment, the surgical instrument may include a handle and anelongated shaft extending in a distal direction from the handle. Theelongated shaft may include a distally located fastener deploymentposition from which a fastener may be deployed at a distal end of theelongated shaft. The surgical instrument may also include a fastenerdeployment system to deploy a fastener from the fastener deploymentposition out of the distal end of the elongated shaft. The fastenerdeployment system may be embodied in any number of ways. Further, insome embodiments, the fastener deployment system may include a magazine,or other appropriate structure for containing a plurality of fasteners.Depending upon the particular embodiment, the plurality of fasteners maybe arranged as a nested stack of fasteners, although other arrangementsare also envisioned.

The fastener deployment system may be configured to preload the stack offasteners with a force which is sufficient to facilitate deployment ofthe fasteners but yet less than the force required to deploy a fastener.For example, the application of a preload to the stack of fasteners inthe distal direction may help maintain a distalmost fastener in thefastener deployment position, while also preventing movement of thestack of fasteners in the proximal direction away from the distal end ofthe shaft. In one embodiment, the fastener deployment system may includea follower, or other appropriate component, that is associated with thestack of fasteners such that it displaces one or more fasteners towardsthe fastener deployment position during an actuation cycle of thefastener deployment system.

The surgical instrument may be provided with a preloaded stack offasteners. However, an extended period of time may pass from when thestack of fasteners is loaded into the instrument and actual use of theinstrument for fastener deployment. For example, the fasteners may beloaded into the instrument during assembly by a manufacturer. Anextended period of time may pass, such as many months or even longer,during which the instrument may reside in inventory, be shipped, and bestored at a user facility, such as a hospital, before the surgicalinstrument is eventually employed for fastener deployment. During thistime, the fasteners may undergo deformation during accelerated agingand/or other physical or property changes when subjected to a constantpreload.

In one embodiment, the surgical instrument may include a lock-out toreduce, and preferably prevent, the application of the preload on thestack of fasteners until the surgical instrument is to be used fordeploying one or more fasteners. The lock-out may be attached to aportion of the elongated shaft suitable for interacting with thefastener deployment system in a manner which prevents the preload frombeing applied to the stack of fasteners. When it is desired to use thesurgical instrument for deploying fasteners, the lock-out may bedetached from the shaft to allow the fastener deployment system to applythe preload to the stack of fasteners prior to actuation of theinstrument.

The lock-out may be configured as a clip which can be snapped on and offthe elongated shaft. In one embodiment, the clip may include at leastone pair of opposing clip fingers which are attachable to the shaft andan outwardly extending handle configured to be gripped and pulled todetach the clip from the shaft. The clip fingers may be configured toconform to the outer surface of the shaft. For example, in oneembodiment, the clip fingers may have opposing curved shapes whichcorrespond to the shape of the shaft. The clip fingers may havesufficient resilience or flexibility which permits the fingers to openand close for attaching and detaching the clip and gripping theelongated shaft therebetween.

As indicated above, the clip may be configured to interact with thefastener deployment system to lock-out and prevent a preload from beingapplied to the stack of fasteners until the instrument is used forfastener deployment. In one embodiment, the clip may include a pin orother suitable component which is associated with the fastenerdeployment system when the clip is attached to the elongated shaft. Thepin may be arranged to extend inwardly from the clip and into aninternal channel of the elongated shaft to prevent distal movement ofthe fastener deployment system toward the stack of fasteners. In oneembodiment, the pin may be arranged to retain the follower in a spacedrelation away from the stack of fasteners so that the follower does notengage and apply a preload or other force against the fasteners.Detaching the clip from the elongated shaft and removal of the pin fromthe internal channel allows the follower to move into engagement withand apply a preload force against the fasteners to move, if necessary,and hold the distalmost fastener in the fastener deployment position forsubsequent fastener deployment upon actuation of the fastener deploymentsystem.

The clip may be formed as a one-piece component although any suitablearrangement may be employed. The pin may be a separate component whichis integrated with the clip. For example, in one embodiment, the pin maybe insert molded to the clip. Such an arrangement allows the use of apin fabricated from a relatively stronger material, such as a metal, ascompared to the clip, which may be formed of a plastic material.However, the lock-out may be constructed in any suitable manner.

In some situations, the lock-out may be considered a sharp object due tothe presence of a pin or similar component which could require disposalof the lock-out in accordance with a particular protocol for handlingsharps. For example, the lock-out may need to be placed in a sharpscontainer for subsequent disposal. To reduce the incidence of apotential contact by an individual handling the lock-out, it may bedesirable to provide a cover or other suitable arrangement to shield thepin or other potential sharp component.

In one aspect, the lock-out may include a shroud configured to cover theclip fingers and the pin therein and thereby shield the pin from contactby an individual when the lock-out is detached from the shaft of thesurgical instrument. The shroud may be configured to open and close soas to permit attachment and detachment of the lock-out to and from theshaft. When closed, the shroud may have a tubular-like configurationdesigned to wrap about the clip fingers as well as the elongated shaftwhen the lock-out is attached to the shaft.

For some situations, it may be desirable to avoid a loose componentwithin a particular environment, such as an operating room. For example,a loose component within an operating room could potentially be droppedinto a patient or otherwise become misplaced and require time to locateand account for the component. Thus, it may be desirable to avoid havinga loose lock-out which potentially could become misplaced when it isdetached from the shaft of the surgical instrument.

According to one aspect, the lock-out may be coupled to the packagingtray or a blister pack for the surgical instrument. When the lock-out isdetached from the instrument to prepare the instrument for use, thelock-out will remain attached to the tray so that it will not becomeinadvertently misplaced during a surgical procedure. The lock-out may becoupled to the tray with a tether, such as a strap, having one endattached to the tray and its opposing end attached to the lock-out. Thetether may be configured with a length which is sufficient to permitremoval and manipulation of the instrument while also maintaining thedetached lock-out in relatively close proximity to the tray so that thelock-out does not dangle from the tray when it is detached from theinstrument.

Because the lock-out may be considered a sharp object, it may bedesirable to detach the lock-out from the tray to facilitate its properdisposal following surgery. For example, the tether may be cut ordetached from either the tray or the lock-out to detach the lock-outfrom the tray. In one embodiment, the lock-out may be configured tofacilitate its detachment from the tether. The lock-out may include aslot or other suitable relief configured to permit removal of thetether, for example, by slipping the tether through the slot and fromthe lock-out.

In addition to deploying the fastener, actuation of the fastenerdeployment system may also result in the distal displacement of thefollower so as to distally displace the stack of fasteners towards thefastener deployment position and position a next distalmost fastener inthe fastener deployment position. The fastener deployment system maydisplace the follower in any appropriate fashion. For example, in oneembodiment, the follower may be associated with a driveshaft of thefastener deployment system such that distal displacement of thedriveshaft distally displaces the follower. Proximal movement of thefollower may also be prevented through the use of an anti-backup elementassociated with the follower. Regardless of the specific manner in whichthe follower is displaced, the follower may be arranged and adapted toprovide a controlled force to the stack of fasteners duringdisplacement. The force applied to the stack of fasteners may be anyappropriate force, and in one embodiment may be less than the actuationforce applied to deploy a fastener from the fastener deploymentposition.

In certain embodiments, the follower may be constructed in anyappropriate fashion such that it applies similar forces to the stack offasteners during subsequent actuation cycles of the fastener deploymentsystem. For example, the follower may include a driver which isassociated with the fastener deployment system such that actuation ofthe fastener deployment system distally displaces the driver. The drivermay also be associated with a compressible elastic component which isassociated with a pusher. The elastic component may be adapted andarranged to provide a controlled force to the pusher upon displacementof the driver. The elastic component may comprise a coil spring, aconical spring, a pneumatic spring, an appropriately shaped componentmade of a compressible material (e.g. rubber), or any otherappropriately shaped and sized compressible component capable ofapplying a force to the stack of fasteners when it is compressed. Insome embodiments, in addition to providing a controllable force to thestack of fasteners, the elastic component may be sufficiently flexibleto permit the follower to pass through an articulated portion of theelongated shaft while still applying a force to the stack of fasteners.In such an embodiment, the driver, elastic component, and pusher mayalso be sized and shaped to pass through the elongated shaft in both thestraight and articulated configuration.

While the embodiments described herein refer to, and depict, the driver,elastic component, and pusher as separate components that are physicallyassociated with one another, the current disclosure is not limited tothe use of separate components. For example, in some embodiments, thedriver, elastic component, and pusher may be provided as part of anintegral component.

In some embodiments, the follower may be adapted to provide similarforces to the stack of fasteners during subsequent actuation cycles.Although this may be accomplished in any number of ways, in oneembodiment, the follower may operate in the following manner. Uponactuation of the fastener deployment system, the driver may be distallydisplaced. The distal displacement of the driver may compress theelastic component from a first length to a compressed second length.Subsequent to compressing the elastic component, the elastic componentmay expand from the compressed second length to the original firstlength. As the elastic component expands to the second length, thefasteners may be distally displaced along the elongated shaft towardsthe fastener deployment position. In some embodiments, the differencebetween the first length and the second length may correspond to thelength of one fastener. When the elastic component is in the expandedstate corresponding to the first length, the elastic component may applya first force to the pusher and the stack of fasteners. Subsequently,when the elastic component is in the compressed state corresponding tothe second length, the elastic component may apply a second force to thepusher and the stack of fasteners. As would be expected for a compressedelastic component, the second force is greater than the first force. Insome embodiments, the first force may be approximately zero. However, inother embodiments, it may be desirable to provide a distal bias to thestack of fasteners throughout the actuation cycle to prevent backwardsor proximal movement of the stack of fasteners. In such an embodiment,the first force may be greater than zero and correspond to an initialcompression of the elastic component prior to actuation of the fastenerdeployment system.

In addition to the forces applied to the stack of fasteners by thefollower, restraining forces may also be applied to the stack fastenersto prevent distal movement of the fasteners until the force applied bythe follower exceeds a preselected threshold force. For example, a firstrestraining force may be applied to the stack of fasteners prior to, andduring, actuation of the fastener deployment system. The firstrestraining force may be applied to the stack of fasteners to oppose thefirst force applied to the stack of fasteners by the follower.Consequently, prior to actuation of the fastener deployment system, thestack of fasteners may remain stationary within the elongated shaft.However, during actuation, the elastic component may be compressed to asecond compressed length to apply a greater force to the stack offasteners as noted above. Once the applied force (e.g. the second force)is greater than the first restraining force, the stack of fasteners maybe distally displaced by the follower to position the next fastener inthe fastener deployment position. A second restraining force maysubsequently be applied to restrain the stack of fasteners fromadditional distal movement during that actuation cycle.

Each of the noted restraining force may be provided by one or morerestraints. Further, the restraints may be embodied in any number offashions. For example, the restraints may include: one or more tabs thatextend inwards and distally relative to the elongated shaft; detentarrangements; and other appropriate features. Further, the restraintsmay be integrally formed with the elongated shaft, or the restraints maybe formed separately and subsequently assembled with the elongated shaftusing any appropriate fashion including, but not limited to, welding,soldering, brazing, adhesives, mechanical couplings, fasteners, andinterference fits.

In some embodiments, in addition to providing the restraining forces tothe stack of fasteners, the restraints may also be used to define thefastener deployment position. For example, a head, or other appropriatefeature, of a fastener may be retained between the first and secondrestraints to define the fastener deployment position.

In addition to providing a follower to control the forces applied to thestack of fasteners, as noted above, it may be desirable to provide amechanism for maintaining the orientation of the fasteners within theelongated shaft as the stack of fasteners is displaced towards thefastener deployment position by the follower. In one embodiment, a guidesurface may be sized and shaped to interact with a corresponding surfaceon at least a portion of the fasteners to maintain the orientation ofthe fasteners as they move within the elongated shaft. In someinstances, the corresponding surface on the fastener may be shaped suchthat it is complementary both in shape and size to the guide surface.The guide surface may be positioned on any appropriate component of theelongated shaft, or a component that is disposed within the elongatedshaft, that interacts with the fasteners as they are moved through theelongated shaft. Further, the guide surface may extend along a distalportion of the component, a portion of the component corresponding tothe stack of fasteners, or the entire length of the component as thecurrent disclosure is not limited as to the location and extent of theguide surface.

It should be understood that the guide surface and the correspondingsurfaces on the fasteners may include any combination of appropriateshapes and/or features that are capable of maintaining the orientationof the fasteners. For example, the guide surface and the correspondingsurfaces on the fasteners may include: corresponding flats; a protrusionand corresponding groove; and other complementary arrangements as shouldbe apparent to one of ordinary skill in the art.

In one particular embodiment, the fasteners may be disposed within aninternal channel of a reciprocating driveshaft that reciprocates in aproximal and distal direction. Further, the guide surface may beincorporated with the interior surface of the channel. In such anembodiment, the guide surface may interact with the correspondingsurface of the fasteners to maintain an orientation of the fastenerswithin the reciprocating driveshaft. During actuation of the fastenerdeployment system, the driveshaft may be moved in a distal direction todeploy a fastener prior to moving in a proximal direction in preparationfor the next actuation cycle. During this reciprocating movement of thedriveshaft, the driveshaft may be moved relative to the stack offasteners. Additionally, during, or subsequent to deployment of thefastener, the stack of fasteners may be displaced towards the distal endof the driveshaft to position the next distalmost fastener in thefastener deployment position using any appropriate biasing element. Forexample, the stack of fasteners may be displaced using a follower asdescribed herein. As the stack fasteners are displaced towards thefastener deployment position, and as the driveshaft is moved relative tothe stack of fasteners disposed therein, the guide surface may maintainthe fasteners in a preselected orientation relative to one another andthe driveshaft. As previously noted, maintaining the fasteners in apreselected orientation relative to one another and the driveshaftensures proper alignment of the fasteners and may lower the necessaryforce to move the fasteners through an articulated portion of theelongated shaft.

For the sake of clarity, the currently disclosed embodiments aredirected to a laparoscopic device. However, the current disclosure isnot limited to laparoscopic devices. Instead, the currently disclosedlock-out, followers, restraints, and guide surfaces could be used in anyappropriate device for the deployment of a fastener into tissue. Forexample, any of the currently disclosed components, or combination ofdisclosed components, could be incorporated into an endoscopic device, aborescopic device, a catheter, a surgical instrument for use in “open”procedures, or any other appropriate surgical instrument. Additionally,the surgical instrument may be loaded with one or more fasteners priorto being provided to an end user, or it may be constructed to allow theuser to load the instrument with one or more fasteners. Further, whilethe various embodiments depicted herein are described as being used witha specific fastener, any appropriate fastener could be used with thecurrently disclosed embodiments including a tack, a clip, a staple, apin, a tissue anchor, a bone anchor, or any other appropriate type offastener.

Turning now to the figures, specific embodiments of the surgicalinstrument are described.

FIG. 1 illustrates one embodiment of a surgical instrument 2 fordeploying one or more surgical fasteners. The surgical instrumentincludes a handle 4 and an elongated shaft 6 extending distally from thehandle 4. In addition to fasteners being deployed from a distal end ofthe elongated shaft, the elongated shaft 6 may include an articulableportion 8. A trigger 14 may be provided on the handle to actuate anassociated fastener deployment system 15, as shown in FIG. 2, and deploya fastener into tissue. The surgical instrument may also include alock-out 150 to prevent the fastener deployment system from applying aforce, such as a preload, to fasteners carried by the instrument untilfastener deployment is desired using the instrument.

As illustrated, and as described in more detail below, the lock-out 150may be attached to a portion of the elongated shaft associated with thefastener deployment system 15 to prevent a preload from being applied tothe fasteners. When it is desired to use the surgical instrument fordeploying fasteners, the lock-out 150 may be detached from the shaft toallow a preload to be applied to the fasteners prior to actuation of theinstrument.

The fastener deployment system 15 may be embodied in any number ofdifferent ways. However, in the particular embodiment depicted in FIG. 2the fastener deployment system may include a trigger 14, a rigid linkage20, a shuttle 22, a power assist device 24, and a reciprocatingdriveshaft 26 as well as other components that are not depicted.Actuation of the trigger 14 may distally displace the rigid linkage 20to distally displace the shuttle 22 and store energy in the power assistdevice 24. After a preselected amount of actuation, the power assistdevice 24 may release the stored energy to distally accelerate thedriveshaft 26 and deploy a fastener from the distal end of the elongatedshaft 6.

While a particular power assist device 24 is depicted, the power assistdevice 24 may correspond to any appropriate construction capable ofaiding in deploying a fastener from the elongated shaft 6 of thesurgical instrument. Depending on the particular embodiment, the powerassist device 24 may supply all of the power necessary to deploy afastener in response to actuation of the trigger 14, or it may onlysupply a portion of the power necessary to deploy a fastener. In onespecific embodiment, the power assist device 24 may correspond to thepower assist device disclosed in application Ser. No. 13/804,043,entitled POWER ASSIST DEVICE FOR A SURGICAL INSTRUMENT, filed on Mar.14, 2013. While a surgical instrument including a power assist devicehas been depicted, in some embodiments, the surgical instrument 2 maynot include a power assist device, in which case actuation of thetrigger 14 may displace the driveshaft 26, either directly or indirectlythrough the use of an appropriate transmission, to deploy a fastenerfrom a distal end of the elongated shaft 6.

FIG. 3 presents an exploded view of one embodiment of the elongatedshaft 6 and the various components disposed within the elongated shaft.In the depicted embodiment, the driveshaft 26 is located within theelongated shaft 6. As illustrated by FIGS. 2 and 3, when disposed withinthe elongated shaft 6, the driveshaft 26 extends proximally from theelongated shaft 6 into the handle 4. The surgical instrument alsoincludes a stack of fasteners 28, a follower 34, and an anti-backupelement disposed within an internal channel of the driveshaft 26. Thefollower and/or the anti-backup element may be associated with or partof the fastener deployment system. The stack of fasteners 28 may includeone or more fasteners 30, and in some instances may be a plurality offasteners 30.

In addition to the above components, the surgical instrument may alsoinclude a fastener guide 32 to help maintain the alignment of the stackof fasteners 28, the follower 34, and the anti-backup element 36 withinthe internal channel of the driveshaft 26. While any appropriatestructure may be used, in the depicted embodiment, the fastener guide 32is a distally extending wire positioned in approximately the center ofthe channel of the driveshaft. The fastener guide 32 may be retainedwithin the channel in any appropriate fashion. For example, the fastenerguide 32 may be attached to a portion of the anti-backup element 36, aportion of the handle 4, or any other appropriate structure. Further,the faster guide 32 may be attached using any appropriate methodincluding, but not limited to, adhesives, mechanical interference,clamping, soldering, brazing, and welding.

Upon actuation of the trigger, the fastener deployment system may beactuated resulting in a distal displacement of the driveshaft 26. Asdescribed in more detail below, a distal displacement of the driveshaft26 deploys a distalmost fastener located in the fastener deploymentposition. The driveshaft 26 also distally displaces the follower 34 soas to displace the stack of fasteners 28 and position the nextdistalmost fastener in the fastener deployment position. The follower 34and anti-backup element 36 may be associated such that a distaldisplacement of the follower 34 results in the anti-backup elementextending in the distal direction to prevent a proximal movement of thefollower 34. After deployment of a fastener, and positioning of the nextfastener in the fastener deployment position, the driveshaft 26 may bemoved in a proximal direction to prepare the surgical instrument for thenext actuation while preventing proximal movement of the stack offasteners 28, the follower 34, and the anti-backup element 36.

The interaction between the follower 34 and the driveshaft 26 isdepicted in FIGS. 4-6.

In the depicted embodiment, the follower 34 includes a driver 100, anelastic component 102, and a pusher 104. The driver 100 is adapted tointeract with the driveshaft 26 to displace the follower 34 in a distaldirection. The driver 100 includes tabs 106 which interact with openings124 on the driveshaft 26. The tabs 106 may be flexible and extendoutwards and distally from the driver 100. In addition, the tabs 106 maybe sized, shaped, and arranged such that the tabs 106 may be disposedwithin the openings 124 as the driver 100 is distally moved throughdriveshaft 26. The driver 100 may also include a distal portion 108 a aswell as a shoulder 110. The distal portion 108 a and the shoulder 110may be sized and shaped to retain a distal end of the elastic component102 on the distal portion 108 a. The distal portion 108 a may alsoinclude one or more retention features 116. As illustrated, theretention features 116 may be protrusions located on the distal portion108 a that interfere with the elastic component 102 to retain theelastic component thereon. Alternatively, the elastic component 102 maybe retained on the driver 100 using any appropriate method including,but not limited to, mechanical interference, interlocking features,adhesives, welding, soldering, and brazing. The driver 100 may alsoinclude a coupling 118 located on a proximal portion 108 b. The coupling118 may be adapted and arranged to attach the follower 34 to theanti-backup element 36.

In one embodiment, the elastic component 102 is a coil spring thatextends between the driver 100 and the pusher 104. As noted above, whilea coil spring has been depicted, other springs and appropriatecomponents could be used in place of a coil spring. Regardless of thespecific component used as the elastic component 102, the elasticcomponent 102 may be sized, shaped, and arranged to be associated withboth the driver 100 and the pusher 104. Further, due to the use of aspring, or other appropriate compressible component, as the driver ismoved in a distal direction, the elastic component 102 is compressed toapply a force to the pusher 104. Larger displacements of the driver 100prior to movement of the pusher 104 may result in larger compressions ofthe elastic component 102 and correspondingly larger forces. Dependingupon the particular embodiment, the elastic component 102 may exhibit alinear force to displacement relationship, or a nonlinear force todisplacement relationship, as the current disclosure is not limited inthis fashion.

Similar to the driver 100, the pusher 104 may include a proximal portion112 b and a shoulder 114 that are sized and shaped to retain a distalend of the elastic component 102. The pusher 104 may also include one ormore retention features 116 for retaining the elastic component 102similar to those described above for the driver 100. The pusher 104 mayalso include a distal portion 112 a that is adapted and arranged toapply a force to the most proximally located fastener of the fastenerstack. In some embodiments, the distal portion 112 a may directlycontact at least the proximal most fastener in the stack of fasteners,though embodiments in which the distal portion 112 a indirectly appliesa force to the stack of fasteners are also envisioned.

As depicted in FIG. 5, the driveshaft 26 may include one or morefastener drivers 120 located on the distal end of the driveshaft 26. Insome embodiments, the fastener driver 120 may be one or more flexibletabs that extend inwards and distally from the distal end of thedriveshaft 26. The fastener drivers 120 may be adapted to apply a forceto a fastener located in the fastener deployment position to deploy thefastener from the distal end of the elongated shaft. The driveshaft mayalso include a flexible portion 122 to accommodate movement of thereciprocating driveshaft through the articulable portion of theelongated shaft. In the depicted embodiment, the flexible portion 122 isformed by providing a pattern of slots, or cuts, in the driveshaft 26.As noted above, the driveshaft 26 may also include openings 124 that aresized and shaped to accommodate the tabs 106 of the driver 100 in anexpanded position. One or more sets of openings 124 may be axiallyspaced along one or more surfaces of the driveshaft 124. In someembodiments, the axial spacing between the openings 124 may correspondto the length of a single fastener. In the current embodiment, two setsof openings 124 extend along opposite sides of the driveshaft 26 toaccommodate both of the tabs 106 of the driver 100. The openings 124 mayextend along the entirety of driveshaft 24, or as depicted in thefigures, the openings 124 may extend along a portion of the driveshaft24 corresponding to an initial proximal position of the follower 34 anda final distal position of the follower 34 after all of the fastenershave been deployed from the surgical instrument.

Having described the corresponding features on the driveshaft 26 and thefollower 34, the interactions of these two components during actuationin one possible embodiment will now be described with reference to FIG.6. Prior to actuation, the tabs 106 of the driver 100 may be located inthe expanded state in any one of the corresponding openings 124 of thedriveshaft 26. While the tabs 106 are in the expanded state within acorresponding opening 124, a proximal portion of the driveshaft 124 a,such as a proximal edge of the opening may be axially aligned with aproximal aspect 106 a of a tab 106. Consequently, as the driveshaft 26is moved in a distal direction during actuation, the proximal driveshaftportion 124 a applies a distally directed force to the proximal aspect106 a of the tabs 106 resulting in a distal displacement of the driver100. After the fastener has been deployed, the driveshaft 26 issubsequently moved in a proximal direction. During the proximal movementof the driveshaft 26, a distal portion of the shaft 124 b, such as adistal edge of the openings 124, may be drawn over an exterior aspect106 b, such as an exterior surface, of the tabs. As described in moredetail below, the driver 100 may be prevented from moving backwardsduring the relative movement of the driveshaft 26 and the driver 100.Further, as noted above, the tabs 106 are flexible. Thus, as the distaldriveshaft portion 124 b is drawn over the exterior aspect 106 b of thetabs, the tabs 106 may be displaced inwards and out of the openings 124to permit the relative movement of the driver 100 and the driveshaft 26.The proximal displacement of the driveshaft 26 may be continued untilthe tabs 106 are aligned with the next distally located set of openings124 and the tabs 106 are in the expanded state within the openings 124.Subsequent actuation cycles may result in the driver 100 progressivelymoving in a distal direction as the driver 100 engages with the nextcorresponding set of openings 124 of the driveshaft. In view of theabove, the driver 100 of the follower 34 and the driveshaft 26 may bedescribed as forming two separate components of a walking beam assemblythat is configured to sequentially displace the follower 34 in a distaldirection during each actuation cycle of the fastener deployment system.

FIGS. 7A-7B depict the interaction of the stack of fasteners 28, thefollower 34, and the anti-backup element 36 during an actuation cycle ofthe fastener deployment system. As illustrated in the figures, thepusher 104 may be in contact with a proximally located fastener of thefastener stack 28. The elastic component 102 may also be associated witha proximal portion of the pusher 104 and a distal portion of the driver100. The driver 100 may be coupled to a rack arm 126 of the anti-backupelement 36 by a coupling 130. The driver 100 and rack arm 126 may becoupled in such a manner that distal movement of the driver 100 mayresult in the distal extension of the rack arm 126 relative to a pawlarm 128 of the anti-backup element 36. Thus, as the follower 34 isdistally displaced through the elongated shaft, the anti-backup element36 correspondingly elongates. Consequently proximal movement of thefollower 34 may be prevented by the anti-backup element 36 throughoutthe actuation cycle. As depicted in the figures, coupling 130corresponds to a pin connection. However, any appropriate connection maybe used including, but not limited to, interlocking mechanical features,a set screw, fasteners, adhesives, welding, brazing, and interferencefits.

Prior to actuation, as depicted in FIG. 7A, the elastic component 102 ofthe follower 34 is in the expanded state corresponding to the firstlength and may apply a first distally directed force to the distallylocated pusher 104 and the stack of fasteners 28. The follower 34 andthe stack of fasteners 28 are prevented from moving in a proximaldirection by the anti-backup element 36. In the depicted embodiment, theanti-backup element 36 includes a rack arm 126 which may be moved in thedistal direction, and a pawl arm 128 which remains stationary duringactuation of the surgical instrument.

Referring to FIG. 7B, as the fastener deployment system is actuated, thedriveshaft, not depicted, may apply a force F_(D) to the tabs 106 of thedriver 100 which drives the driver 100 in a distal direction asdescribed above. A proximally directed first restraining force F_(R1)may be applied to the stack of fasteners 28. Initially, the firstrestraining force F_(R1) may be equal to force F_(D). Thus, during theinitial portions of actuation, the stack of fasteners 28 may remainstationary resulting in the compression of elastic component 102 betweenthe pusher 104 and the driver 100. As actuation continues, the forceapplied to the driver 100 may continue to increase as the elasticcomponent 102 is further compressed. This continued compression of theelastic component 102 applies an increasing distally directed force tothe stack of fasteners 28. At some point during actuation, the springmay be compressed to a second length corresponding to the elasticcomponent 102 applying a second distally directed force to the pusher104 and the associated stack of fasteners 28. This second distallydirected force may be greater than the first restraining force F_(R1)resulting in the expansion of the elastic component 102 and distaldisplacement of the pusher 104 and associated stack of fasteners 28, seeFIGS. 7B-7C.

As depicted by the figures, the elastic component 102 continues toexpand from the second length to the first length as the stack offasteners 28 is displaced in the distal direction. As the elasticcomponent 102 approaches the expanded first length, a proximallydirected second restraining force F_(R2) may be applied to the stack offasteners 28 to prevent further distal movement of the stack offasteners. The second restraining force F_(R2) may be greater than thefirst restraining force to oppose both the force applied to the stack offasteners 28 by the elastic component 102 as well as possible kineticenergy stored in the stack of fasteners 28 and follower 34 as they arebeing distally displaced. The second restraining force may also be lessthan the actuation force to deploy a fastener from the elongated shaft.In some embodiments, the second restraining force F_(R2) may be appliedonce a distally located fastener of the stack fasteners 20 has beenpositioned in the fastener appointment position. After the stack offasteners 28 has been distally displaced and the fastener deploymentsystem has been reset, the surgical instrument may be actuated againresulting in further distal displacement of the follower 34 and theassociated stack of fasteners 28.

In addition to displacement of the follower 34 and the associated stackof fasteners 28, actuation of the fastener deployment system may alsoresult in an extension of the anti-backup element 36 as noted above.More specifically, due to the driver 100 and the rack arm 126 beingcoupled, distal displacement of the driver 100 may result in acorresponding distal displacement of the rack arm 126 relative to thepawl arm 128. The distal movement of the rack arm 126 may extend theanti-backup element 36 in a distal direction to prevent backwardsmovement of the driver 100 after the stack of fasteners 28 has beendistally displaced. The interactions of the rack arm 126 and the pawlarm 128 are illustrated in more detail in FIGS. 8A and 8B. Teeth 134 maybe spaced along the axial length of the rack arm 126. A correspondingpawl 132 may be positioned on a distal portion of the pawl arm 128. Thepawl 132 and the corresponding teeth 134 may be adapted and arranged topermit distal movement of the rack arm 126 in response to distalmovement of the driver. The pawl 132 and the corresponding teeth 134 mayalso be adapted and arranged to prevent proximal movement of the rackarm 126. In one embodiment, the distance between the teeth 134 may beapproximately equal to one fastener length. However, embodiments inwhich the distance between teeth 134 is a fraction of a fastener length,or greater than a fastener length, are also envisioned. In addition tothe above, while a rack and pawl system have been depicted for theanti-backup element 36, any appropriate mechanism capable of preventingbackwards movement of the follower and the stack fasteners could beused.

As indicated above, the follower is 34 is configured and arranged toapply a distally directed preload to the stack of fasteners to drive thestack of fasteners toward the distal end of the shaft and maintain thedistalmost fastener in the fastener deployment position. For someapplications, it may be desirable to employ a lock-out prevent thepreload from being applied to the fasteners until it is desired to usethe instrument for fastener deployment.

In one embodiment shown in FIGS. 9A-10, the lock-out 150 may beconfigured as a clip which can be mounted on and removed from theelongated shaft. As illustrated, the clip 150 may include two pairs ofopposing first clip fingers 152 a and second clip fingers 152 b whichare attachable to the shaft 6 and an outwardly extending grip handle 154configured to be grasped and pulled to detach the clip from the shaft.One or more features may be provided to enhance the user's ability tograsp the grip handle pull the lock-out from the shaft. In oneembodiment, one or more raised ribs 156 may extend about at least aportion of the outer periphery of the grip handle. It is to beappreciated that other suitable grip features may be utilized as shouldbe apparent to one of skill in the art.

The clip fingers 152 a, 152 b may be configured to conform to the outersurface of the shaft 6. For example, in one embodiment, the clip fingers152 a, 152 b may have opposing curved shapes which correspond to theshape of the shaft. The clip fingers may have sufficient resilience orflexibility which permits the fingers to open and close for attachingand detaching the clip and gripping the elongated shaft therebetween.Although illustrated as having two pairs of opposing clip fingers, itshould be understood that the lock-out may include any number of clipfingers, including a single pair, or more than two pairs. Moreover,other suitable arrangements for attaching and detaching the lock-out tothe elongated shaft may be employed as should be apparent to one ofskill in the art.

The grip fingers may be arranged in any suitable configuration tofacilitate attachment and detachment of the lock-out relative to theelongated shaft. As shown in FIGS. 9A-9B, the clip fingers may bearranged with the first fingers 152 a provided on a first side of thelock-out being spaced apart by a first length L₁ and the second fingers152 b provided on a second opposite side of the lock-out being spacedapart by a second length L₂ which is different from the first length L₁.In one embodiment, the first length L₁ between the first fingers 152 ais less than the second length L₂ between the second fingers 152 b. Asillustrated, the first fingers 152 a may be located inward of the secondfingers 152 b, and the second fingers 152 b may be located at oppositeends of the lock-out.

The lock-out 150 may also include a pin 158 which is configured tocooperate with the fastener deployment system when the clip is attachedto the elongated shaft. As illustrated in FIG. 10, the pin 158 may bearranged to extend inwardly from the grip handle 154, through acorresponding hole 160 in the elongated shaft 6, and into an internalchannel 162 of the shaft to prevent distal movement of the fastenerdeployment system toward the fasteners. In one embodiment shown in FIG.10, the pin 158 may be arranged to maintain the follower 34 in a spacedrelation away from the stack of fasteners 28 so that the follower doesnot engage and apply a preload or other force against the fasteners.More particularly, the clip is positioned so that the pin 158 extendsthrough the shaft and is located between the stack of fasteners 28 andthe follower 34 with the pin 158 engaging the shoulder 114 of thedistally biased pusher 104. Detaching the clip 150 from the elongatedshaft and removal of the pin 158 from the internal channel allows thepusher 104 to move into engagement with the proximal-most fastener 30and apply a preload force against the stack of fasteners 28 forsubsequent fastener positioning and deployment upon actuation of thefastener deployment system.

In one exemplary embodiment, the lock-out may have an overall length Lof about 1.25 inches with the first fingers 152 a spaced apart by alength L₁ of about 0.65 inches and the second fingers being spaced apartby a length L₂ of about 1.09 inches. The clip fingers 152 may beconfigured with a curvature having an inner diameter of about 0.22inches with the free ends of the fingers being spaced apart by a widthW₁ about 0.15 inches. The grip handle 154 may have a length L3 from thecenter of the clip fingers of about 1.18 inches. The pin 158 may have adiameter of about 0.03 inches and extend from the surface of the griphandle by a length L₄ of about 0.07 inches. It is to be understood thatthe lock-out dimensions are exemplary and that the lock-out may employany suitable shape and/or sizes as should be apparent to one of skill inthe art.

As indicated above, the lock-out may be considered a sharp object due tothe presence of the pin 158 or similar component which could requiredisposal of the lock-out in accordance with a particular protocol forhandling sharp objects. For example, the lock-out may need to be placedin a sharps container for subsequent disposal. To reduce the incidenceof a potential contact by an individual handling the lock-out, it may bedesirable to provide a cover or other suitable arrangement to shield thepin or other potential sharp component.

In one illustrative embodiment shown in FIGS. 11A-11C, the lock-out 150may include a shroud 170 configured to cover and shield the pin 158 fromcontact by an individual when the lock-out is detached from theelongated shaft 6 of the surgical instrument. The shroud may beconfigured to open and close so as to readily permit attachment anddetachment of the lock-out to and from the shaft. When closed as shownin the figures, the shroud 170 may have a tubular-like configurationdesigned to wrap about and cover the clip fingers 152 a, 152 b as wellas the elongated shaft 6 when the lock-out is attached to the shaft.

The shroud 170 may include a base 172 and a pair of shroud segments 174a, 174 b extending from the base which can be opened relative to theclip fingers for attaching and detaching the lock-out, and closed toencompass the clip fingers and the pin when the lock-out is attached toand detached from the shaft. Each shroud segment 174 a, 174 b may havean arcuate shape configured to form approximately 180° of the tube-likestructure when the shroud is in the closed configuration.

In one embodiment shown in FIG. 12, at least a portion of one of theshroud segments 174 a may extend beyond 180° to form an extension 176,such as a tongue, which is configured to cover the pin should the shroudsegments be collapsed inwardly toward the pin when the lock-out isdetached from the elongated shaft. The opposing shroud segment 174 b mayinclude a recess 181 configured to receive the extension 176 when theshroud segments are closed. As illustrated, the free ends 177 a, 177 bof the shroud segments may be positioned in close proximity to eachother in the closed position to form a relatively narrow gap 179therebetween.

The shroud 170 may be fabricated as a separate component which can becoupled to the lock-out 150. In one embodiment illustrated in FIGS.11A-11C, the shroud 170 may be configured so that the base 172 islocated adjacent the end of the lock-out handle 154 with the shroudsegments 174 a, 174 b extending from the base and about the clip fingers152 a, 152 b. As shown in FIG. 12, the base may include a slot 178 orother suitable opening configured to slidably receive the grip handle154 therethrough to position the shroud on the lock-out.

The lock-out may include one or more locking features to maintain theshroud in its desired position. In one embodiment illustrated in FIGS.11A-11C, a pair of locks 180 may be provided on opposite sides of thegrip handle 154 in proximity to the clip fingers to engage the base 172when the shroud is positioned on the lock-out. Each lock 180 may includea cam-like configuration which facilitates placement of the shroud intoposition between the locks and the clip fingers, and thereafterrestricts movement of the shroud away from the clip fingers. In oneembodiment, each lock 180 may include a ramp-like surface 182 whichfacilitates sliding the shroud over the locks in a direction toward theclip fingers and into position, and an abutment 184 at the end of theramp-like surface which is configured to abut the base and act as a stopto restrict movement of the shroud in a direction away from the clipfingers. It is to be appreciated that any suitable lock arrangement maybe employed as should be apparent to one of skill in the art.

The shroud 170 may be formed to have a flexible configuration whichfacilitates opening and closing the shroud segments, as well asplacement of the shroud on the lock-out. In this manner, the shroud isnot required to grasp and hold the elongated shaft of the instrument asdone by the clip fingers. However, if desired, the shroud segments couldbe configured to assist with holding the lock-out on the shaft as shouldbe apparent to one of skill in the art.

In one embodiment, the shroud may be formed from a material which isconducive to providing flexible characteristics. For example, andwithout limitation, the shroud may be molded from a polyurethane orpolyethylene material, although other suitable materials may be used asshould be apparent to one of skill in the art.

For some situations, it may be desirable to avoid having a loosecomponent within a particular environment, such as an operating room.For example, a loose component could potentially become misplaced andrequire time to locate and account for the component. Thus, it may bedesirable to avoid having a lock-out which potentially can becomemisplaced when it is detached from the shaft of the surgical instrument.

In one embodiment, the lock-out may be coupled to a packaging tray orblister pack of the surgical instrument. When the lock-out is detachedfrom the instrument to prepare the instrument for use, the lock-out willremain attached to the tray so that it will not become inadvertentlymisplaced during a surgical procedure.

In one embodiment illustrated in FIG. 13, the lock-out 150 may becoupled to the tray 186 using a tether 188 having one end attached tothe tray and its opposing end attached to the lock-out. As shown inFIGS. 11A-11C, the tether 188 may include a strap formed as a loop withthe free ends 190 of the strap coupled together with a grommet 192, orother suitable component, which may be attached to the tray with afastener 193, such as a rivet. The looped-end of the strap may becoupled to the grip handle 152 of the lock-out. In one embodiment, thestrap 188 may be looped through a hole 194, such as a slot or othersuitable opening, in the grip handle.

The tether 188 may be configured with a length which is sufficient topermit removal and manipulation of the instrument while also maintaininga detached lock-out in relatively close proximity to the tray so thatthe lock-out does not dangle excessively from the tray when it isdetached from the instrument. In one embodiment, the tether may have alength of about 1.75 inches, although a tether of any suitable lengthmay be employed as should be apparent to one of skill in the art.

Because the lock-out may be considered a sharp object, it may bedesirable to detach the lock-out from the tray to facilitate itsdisposal following a procedure. If desired, the tether may be cut ordetached from either the tray or the lock-out to remove the lock-outfrom the tray. For some applications, the lock-out may be configured tofacilitate its separation from the tether.

In one embodiment illustrated in FIGS. 11A-11B, the lock-out 150 mayinclude a slot 196 (shown in phantom in FIG. 11A) or other suitablepassage configured to permit removal of the tether, for example, byslipping the tether from the lock-out. As shown, the slot 196 may beconfigured to extend from the hole 194 in the grip handle, which is usedfor attaching the tether 188 to the lock-out, through the outerperiphery of the grip handle. The slot 196 may be oriented transverse tothe hole 194 and have a width sufficient to accommodate the thickness,but not the width, of the tether to permit the tether to be slippedthrough the slot when the tether and the lock-out are manipulatedrelative to each other so that the edge of the tether can be slid intoand through the slot. In one embodiment, the slot 196 may be orientedperpendicular to the hole 194. It is to be appreciated that othersuitable arrangements may be employed for detachably coupling thelock-out to the tether as should be apparent to one of skill in the art.

The lock-out may be attached to the elongated shaft during assembly ofthe surgical instrument to minimize the period of time that the stack offasteners would be subjected to a preload. However, it is to beappreciated that the lock-out may be attached to the surgical instrumentat any appropriate time as should be apparent to one of skill in theart.

In one embodiment, the lock-out may be attached by initially displacingthe pusher 104 of the follower 34 in the proximal direction away fromthe stack of fasteners and against the biasing force of the spring 102.The pusher 104 may be displaced a distance sufficient to locate theshoulder 114 of the pusher proximal to the hole 160 through the shaft 6.Thereafter, the lock-out 150 may be attached to the instrument bypushing the clip fingers onto the shaft 6 with the pin 158 extendingthrough the hole 160 and into the internal channel 162 between thefasteners 30 and the pusher shoulder 114. Once the lock-out is attached,the follower 34 may be released so that the spring 102 drives the pusherin the distal direction until the shoulder 114 engages the pin 158 toprevent further advancement of the pusher toward the stack of fasteners28. When engaged by the pin 158, the pusher 104 is spaced an appropriatedistance from the stack of fasteners so that the follower does not applya preload to the fasteners.

In one embodiment, a tether may be attached to the pusher 104 and extendin the proximal direction along the elongated shaft 6 to a locationwhere it is accessible and can be used to retract the follower away fromthe fasteners to facilitate attachment of the lock-out. The tether mayextend through and exit the proximal end of the handle 4 with asufficient length of the tether available for grasping and pulling thepusher proximally. After the lock-out has been attached to the shaft,the tether may be detached and removed from the instrument.

In one embodiment, the tether 164 may be looped through the pusher withtwo segments of the tether extending from the pusher and exiting thehandle 4, as shown in FIG. 14. After the lock-out clip has beenattached, one segment 164 a of the tether may be pulled proximally andto draw the other segment 164 b of the tether distally through thehandle, the shaft, the pusher and eventually proximally back through theshaft and the handle to remove the tether from the instrument.

The lock-out 150 may be formed as a one-piece component although anysuitable arrangement may be employed. The pin 158 may be a separatecomponent which is integrated with the clip. For example, in oneembodiment, the pin 158 may be insert molded to the grip 154. Such anarrangement allows the use of a pin fabricated from a relativelystronger material, such as a metal, as compared to the clip, which maybe formed of a plastic material.

In one embodiment, the clip fingers 152 and the grip body 154 may beintegrally formed of a polycarbonate resin, such as CALIBRE 2061-15FC850122 available from Trinseo. The pin 158 may formed of 304 stainlesssteel, full hard per ASTM F899 and passivated per ASTM A967, and isinsert molded with the clip material to provide a connectiontherebetween having a minimum pull-out force of 5 lbf. However, it is tobe understood that the lock-out may be fabricated from any suitablematerial, using any suitable technique, and/or to provide any suitablepull-out force as should be apparent to one of skill in the art.

FIGS. 15-18 depict an inner tubular member 200 which is a component ofthe elongated shaft 6. The inner tubular member 200 includes the rigidstraight portion 12 which forms the distal end of the elongated shaft 6.The inner tubular member may also include one or more first restraints202 and one or more second restraints 204 located within the rigidstraight portion 12. As depicted in FIG. 15, the two second restraints204 are distally located relative to a first restraints 202. The firstrestraint may be adapted and arranged to provide the first restrainingforce to the stack of fasteners during actuation. Correspondingly, thesecond restraints 204 may be adapted and arranged to provide the secondrestraining force to the stack fasteners during actuation. As notedpreviously, the first restraining force may be less than the secondrestraining force. The different restraining forces may be provided inany number of ways as the current disclosure is not limited to themanner in which the restraining forces are applied to the stack offasteners. In some embodiments the restraints may be integrally formedwith elongated shaft, or a component of the elongated shaft.Alternatively, the restraints may be formed separately and assembledwith elongated shaft in any appropriate fashion including, but notlimited to, welding, soldering, brazing, adhesives, interference fits,and fasteners.

The different first and second restraining forces may be provided in anyappropriate manner. For example, in one embodiment, differentcompliances of the first and second restraints may be used to providethe different first and second restraining forces. More specifically,the second restraints may be less compliant than the first restraints.In another embodiment, the different first and second restraining forcesmay be provided using different numbers of the first and secondrestraints. In such an embodiment, a greater number of the secondrestraints may be used as compared to the number of first restraints.While specific methods of providing the different restraining forceshave been noted above, other ways of providing the restraining forcesare also contemplated.

In one possible embodiment, and as depicted in FIGS. 15-18, the firstand second restraints 202 and 204 may correspond to tabs that extendinwards and distally relative to the inner tubular member 200 of theelongated shaft. To provide the desired first and second restrainingforces, a single more compliant first restraint 202 and two lesscompliant second restraints 204 are incorporated into the rigid straightportion 12 of the inner tubular member 200 of the elongated shaft. Thetabs corresponding to the second restraints 204 may have reduced lengthsand/or increased widths as compared to the tab corresponding to thefirst restraint 202. Without wishing to be bound by theory, this resultsin the second restraints 204 being less compliant than the firstrestraint 202. Consequently, due to the use of two less compliant tabsfor the second restraints 204 as compared to a single more compliant tabfor the first restraint 202, the depicted embodiment is adapted toprovide a second restraining force that is greater than the firstrestraining force. It should be understood that while a particulararrangement of first and second restraints has been depicted in thefigures and described above, other embodiments for providing the firstand second restraining forces are also possible.

The interaction between the first restraints 202, the second restraints204, the fasteners 30, and the driveshaft 26 of the fastener deploymentsystem are illustrated by FIGS. 19A-19C depicting a series ofcross-sections of a distal portion of the elongated shaft 6 duringactuation of the fastener deployment system. Prior to actuation, adistally located fastener 30 is positioned in the fastener deploymentposition 206. The fastener deployment position 206 may be defined by therelative locations of the first restraints 202 and the second restraints204. The first restraints 202 and the second restraints 204 may definethe fastener deployment position by retaining the head 30 a of afastener 30 between them prior to actuation. Retaining a fastener 30 inthe fastener deployment position 206 using the restraints 202 and 204may beneficially prevent a fastener from inadvertently being displacedout of the elongated shaft 6 as well as providing a consistent positionof a fastener for subsequent deployment. Upon actuation of the fastenerdeployment system, the driveshaft 26 is distally displaced resulting inthe fastener drivers 120 applying a force to the fastener 30 located inthe fastener deployment position 206. The applied actuation force isgreater than the second restraining force provided by the secondrestraints 204 resulting in the distal displacement and deployment ofthe fastener as depicted in FIG. 19B. As noted above, the stack offasteners may have a separate force applied to distally displace thestack of fasteners and position the next fastener in the fastenerdeployment position 206 for the next actuation cycle. As the driveshaft26 is withdrawn in a proximal direction to reset the fastener deploymentsystem for the next actuation cycle, the fastener drivers 120 deformaround and past the head 30 a of the fastener 30 located in the fastenerdeployment position 206, see FIG. 19C. As depicted in the figure, thetabs corresponding to the first and second restraints 202 and 204 may bearranged and adapted to resist proximal movement of a fastener 30located distally from the restraints 202 and 204. Consequently, proximalmovement of a fastener 30 located in the fastener deployment position206 may be prevented by the first restraint 202 as the driveshaft ismoved in the proximal direction. Once the driveshaft 26 has been fullymoved in the proximal direction, the surgical instrument is ready todeploy the next fastener.

While the above described embodiments have been directed to a followerthat is driven by the reciprocating action of a driveshaft in a proximaland distal direction, other embodiments are possible. For example, inone embodiment, the follower may be associated with a rotatingdriveshaft such that rotation of the driveshaft may result in a distaldisplacement of the follower and the associated fasteners disposedwithin the driveshaft. In another exemplary embodiment, the follower maybe associated with another component of the fastener deployment systemsuch that actuation of the fastener deployment system results in adistal movement of the follower. For example, the follower may beassociated with the trigger 14, the rigid linkage 20, or the shuttle 22.Further, the follower may be directly, or indirectly, associated withany of the above components.

As noted previously, in addition to displacing the stack of fasteners toposition the next fastener in the fastener deployment position, in someembodiments, it may be desirable to maintain a particular orientation ofthe fasteners within the elongated shaft. FIG. 20 depicts a schematicexploded view of the elongated shaft 6 and the driveshaft 26 which maybe disposed within the interior of the elongated shaft 6. The depictedpattern of slots formed in the exterior of the elongated shaft 6 impartflexibility to the portion of the elongated shaft 6 corresponding to thearticulable portion 8. In the depicted embodiment, the driveshaftincludes an internal channel to accommodate one or more fasteners 30disposed therein. The driveshaft 26 may also include a guide surface136. The guide surface 136 may be any appropriate shape, and as depictedin the figure, may correspond to a flat extending along the axialdirection of the driveshaft 26. The guide surface 136 may interact witha corresponding surface on the fasteners 30 to maintain an orientationof the fasteners while they are disposed within the driveshaft 26 and asthe driveshaft reciprocates between a distal position and a proximalposition during actuation. In addition to the guide surface 136, thedriveshaft 26 may also include a fastener driver 120 a that interactswith the corresponding surface on the fasteners 30 to maintain theorientation of a fastener 30 as it is positioned in the fastenerdeployment position.

In the depicted embodiment, a flat corresponding to the guide surface136 is present on an internal surface of the internal channel of thedriveshaft 26. Additionally, the guide surface 136 may optionally bepresent on an exterior surface of the driveshaft 26 as well. While aparticular shape has been depicted for the guide surface 136, anyappropriate shape or combination of features could be present on thedriveshaft 26 to maintain an orientation of the fasteners 30 disposedtherein. For example, the guide surface 136 may correspond to aprotrusion, a groove, or any other appropriate shape. Further, the guidesurface 136 may extend along any appropriate portion of the driveshaft26. For example, the guide surface 136 may extend along a distal portionof the driveshaft, a flexible portion 122 of the driveshaft, a portionof the driveshaft corresponding to the stack of fasteners located withinthe driveshaft, or the entire length of the driveshaft as the currentdisclosure is not limited in this fashion.

FIGS. 21-23 depict one possible embodiment of a fastener 30 for use withthe driveshaft 26. The depicted embodiment of the fastener 30 includes:a head 30 a; a shaft 30 b extending from the head 30 a; and a barbed end30 c located at a distal end of the shaft 30 b. A surface 138corresponding to the guide surface 136 of the driveshaft may be disposedon the head 30 a. The surface 138 may be sized and shaped to complementthe guide surface 136 the driveshaft such that the fastener 30 smoothlyinterfaces with the internal surfaces of the driveshaft 26. In thedepicted embodiment, the surface 138 corresponds to a flat such that across-section of the head 30 a includes a flat portion and a roundportion sized and shaped to complement corresponding flat and roundportions of a cross-section of the internal channel of the driveshaft.While the surface 138 corresponding to the guide surface 136 has beendepicted as being located on the head 30 a of the fastener, the surface138 may be located on any appropriate portion of the fastener 30. Forexample, a portion of the shaft 30 b or barbed end 30 c could include acorresponding surface, or feature, that is shaped, sized, and arrangedto interact with the guide surface 136 of the driveshaft to maintain anorientation of the fastener 30.

In addition to the surface 138 present on the fastener 30 whichcorresponds to the guide surface 136, the fastener 30 may also include athrough hole 140 extending distally from a proximal surface of the head30 a through the shaft 30 b and the barbed end 30 c. The through hole140 may be sized and shaped to accommodate the fastener guide, asdescribed above, to maintain the alignment of the fasteners 30 withinthe elongated shaft. The through hole 140 may be centrally located,radially offset, or arranged in any other appropriate location as thecurrent disclosure is not limited as to where the through hole 140 islocated. While it may be desirable to include a through hole 140 to helpmaintain the alignment of the fasteners 30 within the elongated shaft,it may also be desirable in certain embodiments to provide a pointed tip142 on the fastener as depicted in the figure. However, embodimentsusing a blunt tip and an associated piercing needle are also envisioned.To accommodate the through hole 140, the pointed tip 142 may be radiallyoffset relative to the through hole 140.

FIG. 24 depicts a distally located fastener 30 disposed within theinternal channel 140 of the driveshaft 26. As illustrated by the figure,guide surface 136 and the fastener driver 120 a of the driveshaft 26 arealigned with the corresponding surface 138 of the fastener 30. Due tothe interaction of the flat portions of the internal channelcross-section and the fastener head (i.e. the guide surface 136 andcorresponding surface 138), as well as the round portions of theinternal channel cross-section and the fastener head, the fastener 30may be maintained in a preselected orientation throughout the length ofthe driveshaft 26.

FIG. 25 depicts the fastener 30 and driveshaft 26 of FIG. 24 disposedwithin the elongated shaft 6. As best illustrated by FIG. 19B, in someembodiments, the fastener drivers 120 may extend distally relative tothe first and second restraints 202 and 204 when the driveshaft 26 isdistally displaced to deploy a fastener. Consequently, it may bedesirable to arrange the fastener drivers 120 and the first and secondrestraints 202 and 204 such that they do not interfere with one anotherduring distal displacement of the driveshaft. In the depictedembodiment, the fastener drivers 120 are arranged in a triangularpattern at a distal end of the driveshaft 26 and the first and secondrestraints 202 and 204 are arranged in another corresponding triangularpattern around the internal surface of the elongated shaft 6 such thatthe fastener drivers 122 do not interfere with the first and secondrestraints 202 and 204 during the distal displacement of the driveshaft.It should be understood that while a particular number and arrangementof the fastener drivers and restraints has been depicted in the figuresand described herein, the current disclosure is not limited in thismanner. Instead, any appropriate number and arrangement of fastenerdrivers and restraints may be used. Further, other appropriate types offastener drivers and restraints may also be used.

As indicated above, the elongated shaft 6 may include an articulableportion 8. The articulable portion may be articulated between a firstposition, such as an unarticulated (i.e. straight) position, and asecond position, such as a fully articulated position, using thearticulation control 10. In some embodiments, the articulable portion 8may be articulated only between the first and second positions. In otherembodiments, the articulable portion 8 may be articulated to one or morepreselected articulated positions, or any arbitrary (i.e. notpreselected) articulated position as the current disclosure is notlimited in this fashion. Further, depending upon the embodiment, thearticulable portion 8 may only be articulated in one direction, or itmay be articulated in two directions. For example, the articulableportion 8 may be articulated between approximately 0° and 90°, 0° and45°, −90° and 90°, −180° and 180° or any other appropriate range ofangles. In addition, in some embodiments the articulable portion 8 mayarticulate about two different axes (e.g. articulation in the horizontaldirection and vertical direction).

In some embodiments, it may be desirable to rotate the elongated shaft 6to facilitate positioning of the distal tip. One such embodiment isdepicted in FIGS. 1 and 18. The rotation of the elongated shaft 6 may beprovided in any appropriate manner. For example, the elongated shaft 6may simply be adapted to be rotatable to at least a portion of thehandle 4. Alternatively, a portion of the handle 4 including theelongated shaft 6 may be rotatable relative to another portion of thehandle 4, such as the portion including the grip. One such embodiment isdepicted in FIG. 1. In the depicted embodiment, the surgical instrument2 includes a first handle portion 16 and a second handle portion 18including the elongated shaft 6. The first and second handle portions 16and 18 may be constructed and arranged in any appropriate fashion to berotatable relative to one another. It should be understood that while asurgical instrument including a rotatable elongated shaft 6 or handle 4is depicted in the figures, a surgical instrument including a unitaryhandle and/or an elongated shaft 6 that is stationary relative to thehandle are also possible as the current disclosure is not limited inthis manner.

In certain applications, it may be advantageous to include a rigidstraight portion 12 distally located from the articulable portion 8. Forexample, and without wishing to be bound by theory, when a driveshaftapplies a force to a fastener as it goes around a curve, the forceapplied by the driveshaft to a proximal portion of the fastener may notbe aligned with the deployment direction of the fastener. This mayresult in a portion of the applied force being directed against a sideof the elongated shaft 6. In contrast, when a driveshaft applies a forceto a fastener along a straight section, the applied force is alignedwith the deployment direction of the fastener. Thus, including a rigidstraight portion 12 that distally extends from the articulable portion 8for a given length may enable the driveshaft to apply a reducedactuation force to deploy the fastener since the applied actuation forcemay be aligned with the deployment direction. Further, applying anactuation force that is aligned with the deployment direction may alsoimprove the consistency of fastener deployment as the surgicalinstrument is varied between different articulation angles. In additionto the benefits noted above, the rigid straight portion 12 may alsoincorporate other components or features to aid in the positioning anddeployment of a fastener from the surgical instrument. While a surgicalinstrument 2 including a distal rigid straight portion 12 has beendescribed herein, and depicted in figures, it should be understood thatembodiments are also envisioned in which the articulable portion 8extends all the way to the distal end of the elongated shaft 6 such thatthe surgical instrument does not include a distal rigid straightportion.

While the present teachings have been described in conjunction withvarious embodiments and examples, it is not intended that the presentteachings be limited to such embodiments or examples. On the contrary,the present teachings encompass various alternatives, modifications, andequivalents, as will be appreciated by those of skill in the art.Accordingly, the foregoing description and drawings are by way ofexample only.

What is claimed is:
 1. A surgical instrument system comprising: a tray;a surgical instrument loaded in the tray, the surgical instrumentincluding: a handle; an elongated shaft extending in a distal directionfrom the handle; a stack of fasteners located within the elongatedshaft; and a fastener deployment system configured to deploy at leastone of the fasteners from the elongated shaft in the distal direction inresponse to actuation thereof, the fastener deployment system configuredto engage and apply a first load to the stack of fasteners in the distaldirection prior to actuation thereof; a lock-out removably attached tothe elongated shaft, the lock-out configured and arranged to prevent thefastener deployment system from applying the first load to the stack offasteners while the lock-out is attached to the elongated shaft; and atether coupling the lock-out to the tray so that the lock-out remainsattached to the tray when the lock-out is detached from the elongatedshaft.
 2. The surgical instrument of claim 1, wherein the lock-out isconfigured to be detached from the tether.
 3. The surgical instrument ofclaim 2, wherein the lock-out includes an opening configured to permitthe tether to pass therethrough and detach the lock-out therefrom. 4.The surgical instrument of claim 1, wherein the lock-out clip includes apin extending through a hole in the elongated shaft, the pin locatedbetween the stack of fasteners and the fastener deployment system toprevent the fastener deployment system from applying the first load tothe stack of fasteners while the lock-out is attached to the elongatedshaft.
 5. The surgical instrument of claim 4, wherein the lock-outincludes a shroud configured to shield the pin from external contactwhen the lock-out is removed from the elongated shaft.
 6. The surgicalinstrument of claim 4, wherein the pin retains the fastener deploymentsystem in a spaced relation away from the stack of fasteners.
 7. Thesurgical instrument of claim 1, wherein the lock-out includes at leastone pair of opposed clip fingers configured to receive and engage theelongated shaft therebetween.
 8. The surgical instrument of claim 7,wherein the clip fingers have a curved configuration to extend about theelongated shaft.
 9. The surgical instrument of claim 7, wherein thelock-out includes a shroud configured to cover the opposed clip fingerswhen the lock-out is attached to and/or removed from the elongatedshaft.
 10. The surgical instrument of claim 7, wherein the lock-out clipincludes a grip handle configured to be grasped and pulled to detach thelock-out clip from the elongated shaft, the tether being couple to thegrip handle.
 11. The surgical instrument of claim 10, wherein the gripis coupled to the opposed clip fingers and extends in a radial directionaway from the elongated shaft.
 12. The surgical instrument of claim 1,wherein the stack of fasteners includes a plurality of surgical tacks.